Device Classification Name |
impedance measuring device utilizing oscillation techniques
|
510(k) Number |
K191876 |
Device Name |
PulmoScan |
Applicant |
Cognita Labs, LLC |
700 N Main St. Ste C1 |
Santa Ana,
CA
92701
|
|
Applicant Contact |
Rajoshi Biswas |
Correspondent |
Cognita Labs, LLC |
700 N Main St. Ste C1 |
Santa Ana,
CA
92701
|
|
Correspondent Contact |
Rajoshi Biswas |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 07/15/2019 |
Decision Date | 03/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|